PAT (Process Analytical Technology) is a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.
PAT was introduced by FDA as an initiative to understand and control the manufacturing process and ensure final product quality. The desired goal of PAT is to design and develop processes that can consistently ensure a predefined quality at the end of the manufacturing process.
Implementation of PAT is supposed to:
- Reduce production cycle times by using on-, in-, and/or at-line measurements and controls
- Prevents batch rejects and re-processing
- Considers the possibility of real time release
- Increases automation
- Facilitates continuous processing
PAT Tools for understanding and control are:
- Multivariate data acquisition and analysis tools
- Modern process analyzers or process analytical chemistry tools
- Process and endpoint monitoring and control tools
- Continuous improvement and knowledge management tools
An appropriate combination of some, or all, of these tools may be applicable to a single-unit operation, or to an entire manufacturing process and its quality assurance.
CIMac™ Analytical Columns are designed as process and endpoint monitoring and control tool and are as such enabling technology for PAT. They deliver fast and reliable information about:
- Product quantity and purity
- Impurity tracking
- During both upstream and downstream processing
CIMac™ Analytical Columns help you characterize and understand your process and comply with the desired aims of PAT initiative:
- Product quality and performance achieved and assured by design of effective and efficient manufacturing processes
- Product specifications based on mechanistic understanding of how formulation and process factors impact product performance
- Continuous "real time" assurance of quality